To obtain product DRUG approval, a firm must submit a New Drug Application (NDA), or an Abbreviated New Drug Application (ANDA) to the FDA. For OTC drugs, direct registration and listing are possible.
Drugs sold over the counter without prescription are called over-the-counter (OTC) drugs. OTC drugs are classified under ‘Generally Recognized as Safe and Effective (GRASE) and are exempted from pre-market approval such as ANDA or NDA.
OTC monograph details about what active ingredients may be used, at what level, and for what intended uses in the drug formulation.
Type of Operations FDA mandates Drug Establishment Registration.
- New or pioneer drugs (NDAs),
- Generic copies of the new pioneer drugs (ANDAs),
- OTC drugs
- Homeopathic drugs
- Drug testing labs
- Sterilization facilities etc.
Homeopathic drugs covered in HPUSP that comply with the FDA’s homeopathic drug Compliance Policy Guide (CPG) also do not require FDA approval before they are marketed. Homeopathic drugs must also be registered and listed.
Unless exempted by law, all drug manufacturers must complete the FDA Drug Establishment Registration before they can be marketed in the USA. This is applicable for Generic, Prescription, and OTC drugs, both domestic and foreign import.